Pump clip for a fluid infusion device

ABSTRACT

A pump clip for a fluid infusion device is provided. The pump clip includes a mount. The mount includes wings defined on opposed sides of the mount, a first lock tab to couple the pump clip to the fluid infusion device and a lip. The pump clip includes a base coupled to the mount that defines a second lock tab that engages with the lip to retain the mount in a first position. The mount is pivotable about a first pivot axis into a second position in which the mount is spaced apart from the base. The pump clip includes a clip coupled to the base, the clip pivotable about a second pivot axis relative to the base between a first, clamped position and a second, released position to receive an article.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/383,989, filed on Sep. 6, 2016. This application also claims thebenefit of U.S. Provisional Application No. 62/383,995, filed on Sep. 6,2016. This application claims the benefit of U.S. ProvisionalApplication No. 62/383,999, filed on Sep. 6, 2016. This application alsoclaims the benefit of U.S. Provisional Application No. 62/383,986, filedon Sep. 6, 2016. The disclosure of each of the above referencedapplications is incorporated herein by reference.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tofluid infusion devices for delivering a medication fluid to the body ofa user. More particularly, embodiments of the subject matter relate to apump clip for a portable fluid infusion device that securely couples thefluid infusion device to the user and withstands accidental displacementof the fluid infusion device.

BACKGROUND

Certain diseases or conditions may be treated, according to modernmedical techniques, by delivering a medication or other substance to thebody of a user, either in a continuous manner or at particular times ortime intervals within an overall time period. For example, diabetes iscommonly treated by delivering defined amounts of insulin to the user atappropriate times. Some common modes of providing insulin therapy to auser include delivery of insulin through manually operated syringes andinsulin pens. Other modern systems employ programmable fluid infusiondevices (e.g., insulin pumps) to deliver controlled amounts of insulinto a user.

A fluid infusion device suitable for use as an insulin pump may berealized as an external device or an implantable device, which issurgically implanted into the body of the user. Generally, externalfluid infusion devices include devices designed for use in a generallystationary location (for example, in a hospital or clinic), and devicesconfigured for ambulatory or portable use (to be carried by a user).External fluid infusion devices may establish a fluid flow path from afluid reservoir to the user via, for example, a set connector of aninfusion set, which is coupled to the fluid reservoir.

In the example of the external fluid infusion device as an insulininfusion device, the external fluid infusion device is intended to beused continuously and delivers insulin twenty-four hours a day accordingto a programmed plan unique to each pump wearer. A small amount ofinsulin, or a basal rate, is given continually. This insulin keeps theuser's blood glucose levels in the desired range between meals andovernight. When food is eaten, the user programs the external infusiondevice to deliver a bolus of insulin matched to the amount of food thatwill be consumed. The user determines how much insulin will be givenbased on factors including insulin sensitivity, insulin duration,insulin-on-board, and the like. In many instances, external infusiondevices include a processor that assists the user in making therapydecisions based on information provided by the user including bloodglucose levels, carbohydrate intake, and/or information from theexternal infusion device.

In this instance, as the device is used continuously for deliveringinsulin twenty-four hours a day, it is desirable to secure the device tothe body of the user. In certain instances, a pump clip can enable easyaccess to the external infusion device while allowing the fluid infusiondevice to be securely held in position while being discrete andinconspicuous. Given that a pump clip is often secured to a user'sclothing, however, the fluid infusion device is susceptible toaccidental displacement, caused by bumping/snagging on chairs, seatbelts when exiting a vehicle, contact with door knobs/tables, etc. Theaccidental displacement may pull the pump clip away from the fluidinfusion device, which may cause damage to the pump clip and/or thefluid infusion device. In addition, movement of the infusion set fromaccidental displacement of the fluid infusion device or tubing mayadversely affect the delivery and efficacy of the infusion therapy.

Accordingly, it is desirable to provide a pump clip for a fluid infusiondevice that securely couples the fluid infusion device to the user whilereducing a likelihood of damage to the pump clip and/or fluid infusiondevice from accidental or unintentional displacement of the fluidinfusion device. Furthermore, other desirable features andcharacteristics will become apparent from the subsequent detaileddescription and the appended claims, taken in conjunction with theaccompanying drawings and the foregoing technical field and background.

BRIEF SUMMARY

According to various embodiments, provided is a pump clip for a fluidinfusion device. The pump clip includes a mount. The mount includeswings defined on opposed sides of the mount, a first lock tab to couplethe pump clip to the fluid infusion device and a lip. The pump clipincludes a base coupled to the mount that defines a second lock tab thatengages with the lip to retain the mount in a first position. The mountis pivotable about a first pivot axis into a second position in whichthe mount is spaced apart from the base. The pump clip includes a clipcoupled to the base, the clip pivotable about a second pivot axisrelative to the base between a first, clamped position and a second,released position to receive an article.

Further provided according to various embodiments is a portable fluidinfusion device system. The portable fluid infusion device systemincludes a fluid infusion device having a pump clip interface thatdefines a pair of rails. The portable fluid infusion device systemincludes a pump clip coupled to the pump clip interface. The pump clipincludes a mount. The mount includes wings defined on opposed sidewallsof the mount, a first lock tab and a lip. The wings cooperate with thepair of rails to position the pump clip on the fluid infusion device andthe first lock tab cooperates with the pump clip interface to releasablycouple the pump clip to the fluid infusion device. The pump clipincludes a base coupled to the mount that defines a second lock tab thatengages with the lip to retain the mount in a first position. The mountis pivotable about a first pivot axis into a second position in whichthe mount is spaced apart from the base. The pump clip includes a clipcoupled to the base and the clip is pivotable about a second pivot axisrelative to the base between a first, clamped position and a second,released position to receive an article.

Also provided according to various embodiments is a portable fluidinfusion device system. The portable fluid infusion device systemincludes a fluid infusion device having a pump clip interface thatdefines a pair of rails and a notch. The portable fluid infusion devicesystem includes a pump clip coupled to the pump clip interface. The pumpclip includes a mount. The mount includes wings defined on opposedsidewalls of the mount, a first lock tab and a lip. The wings areconfigured to be slidably received within the pair of rails to positionthe pump clip on the fluid infusion device. The first lock tabcooperates with the notch of the pump clip interface to releasablycouple the pump clip to the fluid infusion device. The pump clipincludes a base coupled to the mount that defines a second lock tab thatengages with the lip to retain the mount in a first position. The mountis pivotable about a first pivot axis into a second position in whichthe mount is spaced apart from the base. The pump clip includes a clipcoupled to the base and the clip is pivotable about a second pivot axisrelative to the base between a first, clamped position and a second,released position to receive an article.

According to various embodiments, provided is a pump clip for a fluidinfusion device. The pump clip includes a clip base having a first endopposite a second end. The clip base defines an aperture through theclip base between the first end and the second end. The clip base ispivotable between a first position and a second position along a firstpivot axis. The pump clip includes a clip pivot base coupled to the clipbase along the first pivot axis. At least a portion of the clip pivotbase is received within the aperture in the first position. The pumpclip includes a clip coupled to the clip pivot base along a second pivotaxis and the clip cooperates with the clip pivot base to receive anarticle.

Further provided according to various embodiments is a portable fluidinfusion device system. The portable fluid infusion device systemincludes a fluid infusion device having a first end opposite a secondend. The portable fluid infusion device system includes a pump clipcoupled to the first end and to the second end. The pump clip includes aclip base having a first base end opposite a second base end. The clipbase defines an aperture through the clip base between the first baseend and the second base end. The clip base has a first base sideopposite a second base side. The second base side is coupled to thefluid infusion device. The clip base is pivotable between a firstposition and a second position along a first pivot axis. The pump clipincludes a clip pivot base coupled to the first base side of the clipbase along the first pivot axis such that at least a portion of the clippivot base is received within the aperture in the first position and theclip pivot base is spaced apart from the clip base in the secondposition. The pump clip includes a clip coupled to the clip pivot basealong a second pivot axis and the clip cooperates with the clip pivotbase to define a slot to receive an article.

Also provided according to various embodiments is a portable fluidinfusion device system. The portable fluid infusion device systemincludes a fluid infusion device having a first end opposite a secondend. The portable fluid infusion device system includes a pump clipcoupled to the first end and to the second end. The pump clip includes aclip base having a first base end opposite a second base end. The clipbase defines an aperture through the clip base between the first baseend and the second base end. The clip base has a first base sideopposite a second base side. The second base side is coupled to thefluid infusion device. The clip base is pivotable between a firstposition and a second position along a first pivot axis. The pump clipincludes a clip pivot base coupled to the first base side of the clipbase along the first pivot axis such that at least a portion of the clippivot base is received within the aperture in the first position and theclip pivot base is spaced apart from the clip base in the secondposition. The pump clip includes a first biasing member coupled to theclip base that biases the clip base in the first position. The firstbiasing member includes a first leg coupled to the clip pivot base and asecond leg coupled to the clip base. The pump clip includes a clipcoupled to the clip pivot base along a second pivot axis and the clipcooperates with the clip pivot base to define a slot to receive anarticle.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a perspective view of an exemplary pump clip for an exemplaryfluid infusion device according to various teachings of the presentdisclosure;

FIG. 1A is a perspective view of the pump clip of FIG. 1 exploded fromthe fluid infusion device of FIG. 1;

FIG. 2 is perspective view of the pump clip of FIG. 1 removed from thefluid infusion device, in which a clip base is shown in a first positionand a clip of the pump clip is shown in a first, clamp position;

FIG. 3 is an exploded view of the pump clip of FIG. 2;

FIG. 4 is rear view of the pump clip of FIG. 2;

FIG. 5 is an end view of the pump clip of FIG. 2;

FIG. 6 is a rear perspective view of the pump clip of FIG. 2;

FIG. 7 is a detail view of the pump clip of FIG. 2, taken at 7 on FIG.2, which illustrates a first leg of a first biasing member receivedwithin a clip pivot base of the pump clip;

FIG. 8 is a cross-sectional view of the pump clip of FIG. 2, taken alongline 8-8 of FIG. 2;

FIG. 9A is a schematic environmental illustration of a first action forcoupling the pump clip of FIG. 2 to the fluid infusion device of FIG. 1,which illustrates moving a lock button of the pump clip from a lockposition to an unlock position;

FIG. 9B is a schematic environmental illustration of a second action forcoupling the pump clip of FIG. 2 to the fluid infusion device of FIG. 1,which illustrates positioning a base clip of the pump clip around asecond end of the fluid infusion device;

FIG. 9C is a schematic environmental illustration of a third action forcoupling the pump clip of FIG. 2 to the fluid infusion device of FIG. 1,which illustrates positioning a base clip of the pump clip around afirst end of the fluid infusion device;

FIG. 9D is a schematic environmental illustration of a fourth action forcoupling the pump clip of FIG. 2 to the fluid infusion device of FIG. 1,which illustrates moving the lock button of the pump clip from theunlock position to the lock position;

FIG. 9E is a schematic environmental illustration of a fifth action forcoupling the pump clip of FIG. 2 to the fluid infusion device of FIG. 1,which illustrates positioning an article associated with a user in thepump clip;

FIG. 10 is a perspective view of the pump clip and fluid infusion deviceof FIG. 1, which illustrates the clip base of the pump clip in a secondposition;

FIG. 11 is a side view of the pump clip and the fluid infusion device ofFIG. 1, which illustrates the clip base of the pump clip in the secondposition, and schematically illustrates the clip in the second position;

FIG. 12 is a perspective view of another exemplary pump clip for anexemplary fluid infusion device according to various teachings of thepresent disclosure;

FIG. 13 is a rear perspective view of the pump clip of FIG. 12;

FIG. 14 is a perspective view of another exemplary pump clip for anotherexemplary fluid infusion device according to various teachings of thepresent disclosure;

FIG. 15 is an exploded view of the pump clip of FIG. 14, which alsoillustrates the pump clip exploded from a housing of the fluid infusiondevice of FIG. 14;

FIG. 16 is a perspective view of the pump clip of FIG. 14;

FIG. 17 is a cross-sectional view of the pump clip of FIG. 14, takenalong line 17-17 of FIG. 16, which illustrates a clip of the pump clipin a first, clamped position and a mount of the pump clip in a firstposition;

FIG. 18 is a cross-sectional view of the pump clip of FIG. 14, takenfrom the perspective of line 17-17 of FIG. 16, which illustrates theclip of the pump clip in a second, released position and the mount ofthe pump clip in the first position;

FIG. 19 is a cross-sectional view of the pump clip of FIG. 14, takenfrom the perspective of line 17-17 of FIG. 16, which illustrates theclip of the pump clip in the first, clamped position and the mount ofthe pump clip in a second position;

FIG. 20 is a perspective view of the pump clip and the fluid infusiondevice of FIG. 14, which illustrates the mount of the pump clip in thesecond position and the clip in the first, clamped position;

FIG. 21 is a side perspective view of the pump clip and the fluidinfusion device of FIG. 14, which illustrates how to move the mount ofthe pump clip from the second position to the first position inaccordance with various embodiments;

FIG. 22 is a side perspective view of the pump clip and the fluidinfusion device of FIG. 14, which illustrates an attachment process forcoupling the pump clip to the fluid infusion device in accordance withvarious embodiments;

FIG. 23A is a perspective view of the pump clip and the fluid infusiondevice of FIG. 14, which illustrates a first action to detach the pumpclip from the fluid infusion device when the pump clip is fully engagedwith the fluid infusion device;

FIG. 23B is a detail perspective view taken at 23B of FIG. 23A, whichillustrates a second action to detach the pump clip from the fluidinfusion device; and

FIG. 23C is a cross-sectional view taken along line 23C-23C of FIG. 23B,which illustrates a third action to detach the pump clip from the fluidinfusion device.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and“below” could be used to refer to directions in the drawings to whichreference is made. Terms such as “front”, “back”, “rear”, “side”,“outboard”, and “inboard” could be used to describe the orientationand/or location of portions of the component within a consistent butarbitrary frame of reference which is made clear by reference to thetext and the associated drawings describing the component underdiscussion. Such terminology may include the words specificallymentioned above, derivatives thereof, and words of similar import.Similarly, the terms “first”, “second”, and other such numerical termsreferring to structures do not imply a sequence or order unless clearlyindicated by the context.

As used herein, the term “axial” refers to a direction that is generallyparallel to or coincident with an axis of rotation, axis of symmetry, orcenterline of a component or components. For example, in a cylinder ordisc with a centerline and generally circular ends or opposing faces,the “axial” direction may refer to the direction that generally extendsin parallel to the centerline between the opposite ends or faces. Incertain instances, the term “axial” may be utilized with respect tocomponents that are not cylindrical (or otherwise radially symmetric).For example, the “axial” direction for a rectangular housing containinga rotating shaft may be viewed as a direction that is generally parallelto or coincident with the rotational axis of the shaft. Furthermore, theterm “radially” as used herein may refer to a direction or arelationship of components with respect to a line extending outward froma shared centerline, axis, or similar reference, for example in a planeof a cylinder or disc that is perpendicular to the centerline or axis.In certain instances, components may be viewed as “radially” alignedeven though one or both of the components may not be cylindrical (orotherwise radially symmetric). Furthermore, the terms “axial” and“radial” (and any derivatives) may encompass directional relationshipsthat are other than precisely aligned with (e.g., oblique to) the trueaxial and radial dimensions, provided the relationship is predominatelyin the respective nominal axial or radial direction. As used herein, theterm “transverse” denotes an axis that crosses another axis at an anglesuch that the axis and the other axis are neither substantiallyperpendicular nor substantially parallel.

The following description relates to various embodiments of a pump clip.The geometry of the pump clip can be configured to accommodate a varietyof different portable devices such as, but not limited to, portableexternal infusion systems. In one example, the pump clip is provided foruse with a fluid infusion device of the type used to treat a medicalcondition of a user. The infusion device can be used for infusing fluidinto the body of a user. The non-limiting examples described belowrelate to a medical device used to treat diabetes (more specifically, aninsulin pump), although embodiments of the disclosed subject matter arenot so limited. Accordingly, the infused medication fluid is insulin incertain embodiments. In alternative embodiments, however, many otherfluids may be administered through infusion such as, but not limited to,disease treatments, drugs to treat pulmonary hypertension, ironchelation drugs, pain medications, anti-cancer treatments, medications,vitamins, hormones, or the like. For the sake of brevity, conventionalfeatures and characteristics related to infusion system operation,insulin pump and/or infusion set operation, fluid reservoirs, and fluidsyringes may not be described in detail here. Examples of infusion pumpsand/or related pump drive systems used to administer insulin and othermedications may be of the type described in, but not limited to: U.S.Patent Publication Nos. 2009/0299290 and 2008/0269687; U.S. Pat. Nos.4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,505,709; 5,097,122;6,485,465; 6,554,798; 6,558,351; 6,659,980; 6,752,787; 6,817,990;6,932,584; 7,621,893; 7,828,764; and 7,905,868; which are eachincorporated by reference herein.

Generally, the pump clip configured to hold an external infusion device,such as a fluid infusion device, has various design challenges thatgenerally are not present regarding many other portable electronicdevices. For example, with some embodiments the infusion device isdirectly connected via tubing to an infusion set having a cannulainserted into the user. Thus, while pump clips for portable electronicdevices can allow the electronic device to spin freely, if applied to aportable infusion device the free rotation could lead to tangled ordisplaced tubing and may displace the infusion set. Moreover, since thepump clip is in contact with the user, the size and geometry of the pumpclip needs to be comfortable to wear, and the pump clip needs to be ableto attach to a variety of areas on the user or to various articles orobjects associated with the user to enable the fluid infusion device tobe worn at various locations. Additionally, given the repeated contactwith the user, the pump clip needs to be composed of a materialresistant to exposure to chemicals, such as sun screen, body lotion,finger oils, and detergents to prolong a useful life of the pump clip.

With reference to FIG. 1, a pump clip 100 is shown coupled to a fluidinfusion device 102. In FIG. 1A, the pump clip 100 is shown removed fromthe fluid infusion device 102. The pump clip 100 and the fluid infusiondevice 102 cooperate to define a portable fluid infusion device system99 (FIG. 1). The fluid infusion device 102 may be any fluid infusiondevice known in the art, and thus, the fluid infusion device 102 willnot be discussed in great detail herein. Generally, the fluid infusiondevice 102 is designed to be carried or worn by the user, and to becoupled to the user via the pump clip 100. In one example, the fluidinfusion device 102 is an insulin infusion device, such as the MiniMedParadigm® 500 series Insulin Pump, which is commercially available fromMedtronic MiniMed, Inc. of Northridge, Calif. The fluid infusion device102 may leverage a number of conventional features, components,elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and7,621,893, the relevant content of which is incorporated by referenceherein.

Briefly, with reference to FIGS. 1 and 1A, the fluid infusion device 102includes a housing 104. The housing 104 has a first end 106 and anopposite second end 108. The first end 106 defines a slot 110 and aprotrusion 112 (FIG. 1A). The slot 110 receives a portion of the pumpclip 100 to assist in securing the pump clip 100 to the first end 106 ofthe fluid infusion device 102. The slot 110 has a width W1 (FIG. 1A),which is sized to receive the portion of the pump clip 100. The slot 110may have inward sloping sides to facilitate the alignment of the pumpclip 100 with the slot 110. With brief reference to FIG. 1A, theprotrusion 112 extends outwardly from the slot 110. The protrusion 112cooperates with a portion of the pump clip 100 to retain the pump clip100 on the housing 104 and coupled to the fluid infusion device 102. Theprotrusion 112 generally comprises a rounded tab; however, theprotrusion 112 may have any desired shape to cooperate with the pumpclip 100. With reference back to FIG. 1, as will be discussed, thesecond end 108 is received within a portion of the pump clip 100.

The pump clip 100 includes a clip base 120, a lock button 122, a firstbiasing member or first spring 124, a hinge pin 126, a clip pivot base128, a second biasing member or second spring 130, a clamp pin 132 and aclip 134. With reference to FIG. 2, the pump clip 100 is shown detachedfrom the fluid infusion device 102. As shown, the clip base 120 isconfigured to receive the fluid infusion device 102. The clip base 120includes a first base side 140 opposite a second base side 142, a firstbase end 144 opposite a second base end 146 and an aperture 148. Theclip base 120 is generally composed of a biocompatible polymericmaterial, including, but not limited to, copolyester (Tritan® TX1001 orTritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1),Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin®500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast®2510) and polycarbonate. In one example, the clip base 120 is composedof Tritan® COPOLYESTER MX711. The clip base 120 may be formed usingcasting, printing, molding or another suitable technique.

With reference to FIG. 3, the first base side 140 includes or defines afirst pin post 150, a second pin post 152 and a spring cover 154. Thefirst pin post 150 and the second pin post 152 extend outwardly from thefirst base side 140. The first pin post 150 and the second pin post 152are rounded to provide a smooth contact surface against the user. Thefirst pin post 150 defines a first bore 150 a, and the second pin postdefines a second bore 152 a. The first bore 150 a receives a first end126 a of the hinge pin 126, and the second bore 152 a receives anopposite second end 126 b of the hinge pin 126. The first pin post 150and the second pin post 152 cooperate to retain the hinge pin 126 on theclip base 120. The first bore 150 a and the second bore 152 a aredefined in the respective first pin post 150 and the second pin post 152along an axis A, which is substantially perpendicular to thelongitudinal axis L1 of the clip base 120.

The spring cover 154 is arcuate, and may be substantially cylindrical.The spring cover 154 is defined on the first base side 140 so as to besubstantially evenly spaced apart from the first pin post 150 and thesecond pin post 152. Stated another way, the spring cover 154 issubstantially centered on the first base body 140 between the first pinpost 150 and the second pin post 152. The spring cover 154 is spacedapart from the first pin post 150 and the second pin post 152 such thatrespective portions of the clip pivot base 128 may be received betweenthe first pin post 150 and the spring cover 154, and between the secondpin post 152 and the spring cover 154. The spring cover 154 protects thefirst spring 124, and substantially encloses a portion of a body of thefirst spring 124 such that the first spring 124 is substantiallyconcealed from view when the pump clip 100 is assembled (FIG. 2). Thespring cover 154 defines a spring aperture 154 a, which cooperates withthe second base side 142 to receive the first spring 124.

With reference to FIG. 4, the second base side 142 is shown in greaterdetail. The second base side 142 is substantially flat or planar forbeing positioned against the fluid infusion device 102 (FIG. 1) when thefluid infusion device 102 is coupled to the pump clip 100. The secondbase side 142 includes a spring guide 156, a spring recess 158, a firstpocket or relief 160 and a second pocket or relief 162. The spring guide156 is defined as a concave notch on the second base side 142, whichextends between the spring recess 158 and the aperture 148. The springguide 156 receives a portion of the first spring 124. The spring recess158 is in communication with the spring cover 154 and cooperates withthe spring cover 154 to receive the first spring 124. The first relief160 is defined on the second base surface 142 so as to be substantiallyopposite the second pin post 152 (FIG. 3). The second relief 162 isdefined on the second base surface 142 so as to be substantiallyopposite the first pin post 150 (FIG. 3). The first relief 160 and thesecond relief 162 may provide a mass savings and may aid in themanufacture of the clip base 120.

With reference to FIG. 5, the first base end 144 includes a couplingflange 164. The coupling flange 164 extends outwardly form the firstbase end 144, and generally extends along an axis A1, which issubstantially perpendicular to the longitudinal axis L1 of the clip base120 (FIG. 3). The coupling flange 164 has a width W2, which issubstantially equal to the width W1 of the slot 110 (FIG. 1) so that thecoupling flange 164 may be received onto the fluid infusion device 102.The coupling flange 164 may also include one or more protrusions, suchas a first protrusion 164 a and a second protrusion 164 b. The firstprotrusion 164 a and the second protrusion 164 b extend outwardly from arespective side 164 c, 164 d of the coupling bore 166 and cooperate withmating features defined in the slot 110 to assist in coupling the pumpclip 100 to the fluid infusion device 102. In one example, the firstprotrusion 164 a and the second protrusion 164 b cooperate to form adovetail with the slot 110 (FIG. 1A).

The coupling flange 164 also defines a coupling bore 166, which receivesthe lock button 122. The coupling bore 166 includes a plurality ofridges 168, which are spaced apart about a circumference of the couplingbore 166. Each of the plurality of ridges 168 cooperate with arespective one of a plurality of reliefs 170 defined on the lock button122 (FIG. 3) to retain the lock button 122 within the coupling bore 166.In this example, each of the plurality of ridges 168 include a bulbousportion 168 a, which assists in retaining the lock button 122 within thecoupling bore 166. Each of the plurality of ridges 168 are defined abouta perimeter of the coupling bore 166 and extend radially inward toward acenter of the coupling bore 166. The coupling flange 164 may alsoinclude one or more graphical indicators 172, such as a lock symbol 172a and an unlock symbol 172 b, as shown in FIGS. 12A and 12D, if desired.The lock symbol 172 a and the unlock symbol 172 b provide a visualindicator of a lock position and an unlock position, respectively, forthe pump clip 100 relative to the fluid infusion device 102, as will bediscussed further herein.

With reference to FIG. 3, the second base end 146 is substantiallyC-shaped to fit around the second end 108 of the fluid infusion device102 (FIG. 1). The second base end 146 includes a coupling portion 174and a lip 176. The coupling portion 174 extends outwardly away from theclip base 120 along an axis A2. The axis A2 is substantially parallel tothe axis A1, and is substantially perpendicular to the longitudinal axisL1. The coupling portion 174 defines a channel 178. The channel 178 issized to be adjacent to the second end 108 of the fluid infusion device102 (FIG. 1) to couple the fluid infusion device 102 to the pump clip100. Generally, the channel 178 enables the pump clip 100 to clear abumper defined on a bottom of the housing 104 of the fluid infusiondevice 102. The lip 176 extends outwardly away from the coupling portion174 along an axis A3. The axis A3 is substantially perpendicular to theaxis A2, and substantially parallel to the longitudinal axis L1 of theclip base 120. A curved surface 180 is defined between the lip 176 andthe coupling portion 174 to assist in coupling the fluid infusion device102 to the pump clip 100. The lip 176 and the curved surface 180cooperate to guide the fluid infusion device 102 into the couplingportion 174.

The aperture 148 is defined through the first base side 140 and thesecond base side 142 and extends from the near the first base end 144 tothe second base end 146. The aperture 148 has a thickness T1, which issized and shaped to correspond to a portion of the clip pivot base 128.The aperture 148 is in communication with the spring guide 156.

As will be discussed, the lock button 122 is received within thecoupling bore 166 and retains the pump clip 100 on the fluid infusiondevice 102. The lock button 122 may be optional, in that the pump clip100 may be snap-fit around the fluid infusion device 102, if desired. Inthis example, with reference to FIG. 1, the lock button 122 includes afirst end 182 and an opposite second end 184. The lock button 122 isgenerally cylindrical in shape, and is composed of a biocompatiblepolymeric material, including, but not limited to, copolyester (Tritan®TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron®1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03,Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 orIsoplast® 2510) and polycarbonate. In one example, the lock button 122is composed of Tritan® COPOLYESTER MX711. The lock button 122 may beformed using casting, printing, molding or another suitable technique.The first end 182 includes a key slot 186. The key slot 186 has aconcave bottom surface 186 a that is shaped to receive an implement formoving or rotating the lock button 122 between a lock position and anunlock position. In one example, the instrument is a coin; however, theinstrument may include a screwdriver, fingernail, or other devicecapable of being received in the key slot 186 and applying a force tomove or rotate the lock button 122 within the coupling bore 166.

With reference to FIG. 6, the second end 184 of the lock button 122includes a first lock 190 spaced apart from a second lock 192 and theplurality of reliefs 170. The plurality of reliefs 170 are defined abouta perimeter or circumference of the lock button 122 near the first end182, and cooperate with the plurality of ridges 168 to retain the lockbutton 122 on the coupling flange 164.

The first lock 190 is spaced apart from the second lock 192 about theperimeter or circumference of the lock button 122. In one example, thefirst lock 190 is substantially opposite the second lock 192 about thecircumference of the lock button 122. The first lock 190 and the secondlock 192 include a lock guide 196 and a lock protrusion 198. The lockguide 196 guides the lock button 122 about the protrusion 112 of thefluid infusion device 102 (FIG. 1) to position the lock protrusion 198into contact with the protrusion 112 (FIG. 1). The contact between thelock protrusion 198 and the protrusion 112 retains the pump clip 100 onthe fluid infusion device 102 and inhibits the pump clip 100 fromsliding off of the fluid infusion device 102. The lock guides 196 arereceived through the coupling bore 166, and once the lock button 122 isrotated past the one of the plurality of ridges 168, the lock guides 196retain the lock button 122 within the coupling bore 166. Stated anotherway, the lock guides 196 sit under the plurality of ridges 168, whilethe lock protrusions 198 slide over a top surface of the plurality ofridges 168.

The first spring 124 is received within the clip base 120 and enablesthe clip base 120 to rotate relative to or away from the clip pivot base128 upon the application of a torque greater than the first springtorque of the first spring 124. Thus, the first spring 124 enables theclip base 120 to move from a first position (FIG. 2) to a secondposition and positions in-between (FIG. 10) upon the application of atorque to the fluid infusion device 102 greater than the first springtorque of the first spring 124. As shown, in the first position the clipbase 210 is adjacent to or next to the clip pivot base 128, and in thesecond position, the clip base 210 is spaced apart from the clip pivotbase 128. In one example, the first spring torque applied by the firstspring 124 is about 4.3 inch-ounces (in.-oz.) at the first position(fully closed position), and is about 17.5 inch-ounces (in.-oz.) at thesecond position (fully open position).

The first spring 124 biases the clip base 120 in the first position, andupon removal of a torque that has moved the clip base 120 towards thesecond position, the first spring 124 returns the clip base 120 to thefirst position. Thus, the first spring 124 enables the pump clip 100 towithstand torques caused by the fluid infusion device 102 contactingexternal factors without damaging the fluid infusion device 102 and/orthe pump clip 100, and without impacting an infusion set coupledpercutaneously to the user. The first spring 124 also enables the userto apply a torque to rotate the fluid infusion device 102 withoutdamaging the fluid infusion device 102 and/or the pump clip 100, andwithout impacting an infusion set coupled percutaneously to the user. Inone example, the first spring 124 withstands a torque acting on thefluid infusion device 102 that is less than about 4.3 inch-ounces(in.-oz.). Thus, a torque applied to the fluid infusion device 102 thatis greater than about 4.3 inch-ounces (in.-oz.) causes the clip base 120to move or rotate toward the second position. The first spring 124 iscomposed of a biocompatible metal or metal alloy, such as a nickelcoated music wire. The first spring 124 may be formed through anysuitable technique, such as extrusion, casting, etc. In this example,the first spring 124 is a helical torsion spring, and includes a firstspring leg 200 and a second spring leg 202, which extend from oppositesides of a helical coil body 204. Thus, the first spring leg 200 is at afirst end of the helical coil body 204, and the second spring leg 202 isat a second end of the helical coil body 204.

The first spring leg 200 is coupled to the clip pivot base 128. In oneexample, the first spring leg 200 may be received within a pivot springguide 206 defined on a portion of the clip pivot base 128. Withreference to FIG. 7, a portion of the first spring leg 200 may besubstantially covered by the clip 134 when the pump clip 100 isassembled to assist in retaining the first spring leg 200 within thepivot spring guide 206.

With reference to FIG. 4, the second spring leg 202 is coupled to theclip base 120. In this example, the second spring leg 202 is coupled tothe spring guide 156 of the second base side 142 of the clip base 120.The helical coil body 204 is received within the spring recess 158. Withreference to FIG. 2, the spring cover 154 substantially encloses thehelical coil body 204 to protect the helical coil body 204 and toprotect the user from the helical coil body 204. The helical coil body204 defines an internal passage 204 a that receives the hinge pin 126therethrough.

With reference to FIG. 2, the hinge pin 126 defines a first pivot axisP1 for the movement or rotation of the clip base 120 relative to theclip pivot base 128. The first pivot axis P1 is a first pivot axis forthe pump clip 100, and the first pivot axis P1 is substantiallyperpendicular to a longitudinal axis L2 of the pump clip 100. Withreference back to FIG. 3, the hinge pin 126 has the first end 126 a thatis received within the first pin post 150, and the opposite second end126 b that is received within the second pin post 152. The hinge pin 126is composed of a biocompatible material, and in one example, is composedof a biocompatible metal or metal alloy. In this example, the hinge pin126 is composed of a biocompatible sheet of metal or metal alloy, suchas a stainless steel, which is rolled into a spiral cylinder. Byproviding the hinge pin 126 as cylindrical rolled sheet metal, the hingepin 126 is easily inserted into the first pin post 150, through aportion of the clip pivot base 128, the first spring 124 and into thesecond pin post 152, and once inserted, the hinge pin 126 expands toprovide a radial force that retains the hinge pin 126 within the firstpin post 150 and the second pin post 152.

The clip pivot base 128 is coupled to the clip base 120 and to the clip134. The clip pivot base 128 is composed of a biocompatible polymericmaterial, including, but not limited to, copolyester (Tritan® TX1001 orTritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1),Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin®500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast®2510) and polycarbonate. In one example, the clip pivot base 128 iscomposed of Tritan® COPOLYESTER MX711. The clip pivot base 128 may beformed using casting, printing, molding or another suitable technique.The clip pivot base 128 includes a first clip side 210 opposite a secondclip side 212 and a first clip end 214 opposite a second clip end 216. Awall 218 interconnects the first clip side 210 and the second clip side212. Generally, the wall 218 is received wholly within the aperture 148when the clip base 120 is in the first position, such that a primarysurface S of the first clip side 210 is substantially flush with aprimary surface S1 of the first base side 140. The wall 218 has athickness T2, which is substantially equal to the thickness T1 of theaperture 148. The primary surface S of the first clip side 210 issubstantially flat or planar and smooth, to receive a portion of anarticle associated with a user of the pump clip, such as a belt, shirt,pants, etc.

The first clip side 210 includes a first pivot arm 220, a second pivotarm 222, a spring retainer 224 and a clip recess 226. The first pivotarm 220 and the second pivot arm 222 are spaced apart on the first clipside 210 near and at the first clip end 214. The first pivot arm 220includes a first clip post 228, the pivot spring guide 206 and an arm230 that defines a first pivot bore 232. The first clip post 228 definesa first clip bore 234, which receives a first end 132 a of the clamp pin132. The first clip post 228 also defines a flange relief 236, whichenables a portion of the clip 134 to be received over the first clippost 228. In one example, the flange relief 236 is a portion of thefirst clip post 228 adjacent to the wall 218 that is removed for receiptof the portion of the clip 134. The first pivot arm 220 defines a slopedsurface 220 a that transitions from the first clip post 228 to the arm230. The sloped surface 220 a provides clearance for a movement orrotation of the clip 134 and acts as a guide for the rotation of theclip 134.

The pivot spring guide 206 is defined between the first clip post 228and the first pivot bore 232 along a side 230 a of the arm 230. Thepivot spring guide 206 may extend along an axis that is transverse oroblique to a longitudinal axis L3 of the clip pivot base 128 to aid inretaining the first spring leg 200. The arm 230 extends a distance D1above the wall 218 so that the arm 230 may rest upon a portion of thefirst base side 140 to enable the first pivot bore 232 to be coupled tothe hinge pin 126. As the distance D1 for the arm 230 of the first pivotarm 220 is the same as the distance D1 for an arm 240 of the secondpivot arm 222, the distance D1 is shown in FIG. 3 associated with thearm 240 with the understanding that the distance D1 for the arm 230 isthe same. The arm 230 has a width that is sized to be received on thefirst base side 140 between the first pin post 150 and an end of thespring cover 154. The first pivot bore 232 is defined at a distalmost orterminal end of the arm 230. The first pivot bore 232 receives a portionof the hinge pin 126 therethrough to pivotally couple the clip pivotbase 128 to the clip base 120 (FIG. 7).

The second pivot arm 222 includes a second clip post 242 and the arm 240that defines a second pivot bore 244. The second clip post 242 defines asecond clip bore 246, which receives a second end 132 b of the clamp pin132. The first clip bore 234 of the first clip post 228 and the secondclip bore 246 extend along an axis A3, which is substantiallyperpendicular to the longitudinal axis L2 of the clip pivot base 128.The second clip post 242 also defines the flange relief 236, whichenables a portion of the clip 134 to be received over the second clippost 242. In this example, the flange relief 236 is a portion of thesecond clip post 242 adjacent to the wall 218 that is removed forreceipt of the portion of the clip 134. The second pivot arm 222 definesa second sloped surface 222 a that transitions from the second clip post242 to the arm 240. The second sloped surface 222 a provides clearancefor a movement or rotation of the clip 134 and acts as a guide for therotation of the clip 134.

The arm 240 extends the distance D1 above the wall 218 so that the arm240 may rest upon a portion of the first base side 140 to enable thesecond pivot bore 244 to be coupled to the hinge pin 126. The arm 240has a width that is sized to be received on the first base side 140between an end of the spring cover 154 and the second pin post 152. Thesecond pivot bore 244 is defined at a distalmost or terminal end of thearm 240. The second pivot bore 244 receives a portion of the hinge pin126 therethrough to pivotally couple the clip base 120 to the clip pivotbase 128 (FIG. 7). The arms 230, 240 may also include a relief on aninternal surface that is sized to enable the arms 230, 240 to bepositioned on either side of the spring cover 154.

The spring retainer 224 extends outwardly or upwardly from the firstclip side 210. In one example, the spring retainer 224 is a post, whichis cylindrical. The spring retainer 224 is coupled to the second spring130 and a head 224 a of the spring retainer 224 may act as a stop tolimit a compression of the second spring 130.

The clip recess 226 is defined at or near the second clip end 216 andreceives a portion of the clip 134. The clip recess 226 cooperates withthe clip 134 to define a tortuous path for clamping the pump clip 100 toan article of clothing, for example. In this example, the clip recess226 is substantially rectangular; however, the clip recess 226 may haveany desired shape. In this example, the clip recess 226 has an enclosedbottom surface 226 a, however, it should be understood that the cliprecess 226 may comprise an aperture, which receives a portion of theclip 134.

With reference to FIG. 4, the second clip side 212 is flush with thesecond base side 142 when the clip pivot base 128 is in the firstposition. The second clip side 212 is substantially flat or planar, andmay include one or more recesses, which may aid in the manufacture ofthe clip pivot base 128 and may provide mass savings. With referenceback to FIG. 3, the first clip end 214 includes the arms 230, 240, whichpivotally couple the clip base 120 to the clip pivot base 128. Thesecond clip end 216 includes the clip recess 226.

The second spring 130 is coupled to the clip pivot base 128. In oneexample, the second spring 130 is a leaf spring and includes a firstleaf 250 and a second leaf 252 interconnected by a substantiallyU-shaped body 254. The second spring 130 is composed of a biocompatiblemetal or metal alloy, such as a stainless steel. The second spring 130may be extruded, cast, stamped, machined or otherwise formed. The firstleaf 250 is compressible by a force applied to the clip 134 to move theclip 134 from a first, clamped position to a second, release position.In one example, the force needed to overcome the second spring 130 tomove the clip 134 from the first, clamped position (fully closedposition) is about 1 pound-force (lbf.), and the force needed to movethe clip 134 to the second, release position (fully opened position) isabout 6 pound-force (lbf.). The second leaf 252 defines a spring bore256. The spring bore 256 receives the spring retainer 224 therethroughto couple the second spring 130 to the clip pivot base 128. Generally,the spring bore 256 is circular; however, the spring bore 256 may haveany shape that corresponds with the spring retainer 224 to retain thesecond spring 130 on the clip pivot base 128. The body 254 couples thefirst leaf 250 to the second leaf 252, and provides a second springforce that maintains the clip 134 in the first, clamped position.

With reference to FIG. 2, the clamp pin 132 defines a second pivot axisP2 for the movement or rotation of the clip 134 relative to the clippivot base 128 between the first, clamped position, the second, releaseposition and various positions in-between. The second pivot axis P2 is asecond pivot axis for the pump clip 100, and the second pivot axis P2 issubstantially perpendicular to the longitudinal axis L2 of the pump clip100 and substantially parallel to the first pivot axis P1. The secondpivot axis P2 is offset from or spaced apart from the first pivot axisP1 along the longitudinal axis L2 of the pump clip 100. With referenceback to FIG. 3, the clamp pin 132 has the first end 132 a that isreceived within the first clip bore 234 of the first clip post 228, andthe opposite second end 132 b that is received within the second clipbore 246 of the second clip post 242. The clamp pin 132 is composed of abiocompatible material, and in one example, is composed of abiocompatible metal or metal alloy. In this example, the clamp pin 132is composed of a biocompatible sheet of metal or metal alloy, such as astainless steel, which is rolled into a spiral cylinder. By providingthe clamp pin 132 as cylindrical rolled sheet metal, the clamp pin 132is easily inserted into the first clip post 228, through a portion ofthe clip 134, through the second spring 130 and into the second clippost 242, and once inserted, the clamp pin 132 expands to provide aradial force that retains the clamp pin 132 within the first clip post228 and the second clip post 242.

The clip 134 cooperates with the primary surface S of the clip pivotbase 128 to define a slot, generally indicated by reference numeral 260in FIG. 2, for receipt of an article of clothing or item associated withthe user, such as a shirt, belt, strap, etc. when the clip 134 is in thefirst, clamped position. The clip 134 is composed of a biocompatiblepolymeric material, including, but not limited to, copolyester (Tritan®TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron®1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03,Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 orIsoplast® 2510) and polycarbonate. In one example, the clip 134 iscomposed of Tritan® COPOLYESTER MX711. The clip 134 may be formed usingcasting, printing, molding or another suitable technique. The clip 134includes a first side 262 opposite a second side 264, and a first end266 opposite a second end 268.

The first side 262 is substantially smooth, and includes an arcuate orcurved surface 270 near and at the first end 266. The curved surface 270provides a location for a thumb of a user, for example, to apply a forceto move the clip 134 to the second, release position. The second side264 is substantially smooth, and includes a pair of clip hingeprojections 272, which extend outwardly from the second side 264 nearthe first end 266. The clip hinge projections 272 are spaced apart fromeach other on the second side 264. In this example, each of the cliphinge projections 272 includes a clip bore 274, which receives arespective first end 132 a and second end 132 b of the clamp pin 132.

The second side 264 also includes a clip projection 276 at the secondend 268. The clip projection 276 extends outwardly from the second side264, and is substantially U-shaped. With reference to FIG. 8, the clipprojection 276 cooperates with the clip recess 226 to define a tortuouspath for capturing an article of clothing or other item associated withthe user to secure the pump clip 100 to the particular article ofclothing or other item. Thus, the clip projection 276 enables the clip134 to clamp onto an article of clothing or other item associated withthe user, and the slot 262 also enables the pump clip 100 to be retainedabout a belt, strap, etc. associated with the user, if desired. Thus, itshould be understood that the pump clip 100 is not limited to use justwith belts or straps associated with a user. The second side 264 alsohas a recess 278 which is adjacent to the first leaf 250 of the secondspring 130. The second spring 130 is in compression in the assembly whenthe clip 134 is in the first, clamped position.

With reference to FIG. 11, when a force F is applied to the first end266 of the clip 134 exceeds the spring force from second spring 130, theclip 134 rotates about the second pivot axis P2 defined by the clamp pin132 and the second end 268 of the clip 134 is moved to the second,release position in which the clip 134 is open relative to the clippivot base 128. A width W3 of the opening is at least about 0.4 inches(in.) wide for easy attachment and detachment of the pump clip 100.Although not shown in FIG. 11, the clip pivot base 128 remains engagedwith the clip base 120 when operating the clip 134 due to the firstspring torque from the first spring 124, and due to the application ofthe force to the clip 134 between the clamp pin 132 and the hinge pin126 a moment is only created about the clamp pin 132.

In one example, with reference to FIG. 3, in order to assemble the pumpclip 100, with each of the clip base 120, the lock button 122, the firstspring 124, the hinge pin 126, the clip pivot base 128, the secondspring 130, the clamp pin 132 and the clip 134 formed, the clip pivotbase 128 may be positioned within the aperture 148. With the firstspring 124 received within the spring cover 154, the first spring leg200 of the first spring 124 may be positioned within the pivot springguide 206, and the second spring leg 202 may be positioned within thespring guide 156. With the first pivot bore 232 and the second pivotbore 244 of the clip pivot base 128 coaxially aligned with the internalpassage of the 204 a of the helical coil body 204, the first bore 150 aof the first pin post 150 and the second bore 152 a of the second pinpost 152, the hinge pin 126 may be inserted through the first pin post150 and through to the second pin post 152 to couple the clip pivot base128 to the clip base 120. The spring bore 256 of the second spring 130may be coupled to the spring retainer 224 to couple the second spring130 to the clip pivot base 128. The clip hinge projections 272 may bepositioned over the respective flange relief 236 such that the clipbores 274, the first clip bore 234 and the second clip bore 246 arecoaxially aligned. The clamp pin 132 is inserted through the clip hingeprojections 272 such that the clamp pin 132 passes between the firstleaf 250 and the second leaf 252 of the second spring 130 to couple theclip 134 to the clip pivot base 128. The lock button 122 may be insertedinto the coupling bore 166 of the coupling flange 164.

With the pump clip 100 assembled, the pump clip 100 may be coupled tothe fluid infusion device 102. In one example, with reference to FIG.9A, the pump clip 100 is shown in hands 280 of a user. In this example,an implement 282 is inserted into the key slot 186 and rotated in acounterclockwise direction to move the lock button 122 from the lockposition to the unlock position. In the unlock position, the pump clip100 is capable of being coupled to the fluid infusion device 102, asshown in FIG. 9B. In FIG. 9B, the coupling portion 174 is coupled aboutthe second end 108 of the fluid infusion device 102.

With the coupling portion 174 positioned about the second end 108 of thefluid infusion device 102, with reference to FIG. 9C, the couplingflange 164 may be positioned over the first end 106 of the fluidinfusion device 102. The coupling flange 164 is advanced in the slot 110until the second base side 164 contacts the housing 104 of the fluidinfusion device 102. In this position, the lock button 122 is positionedover the protrusion 112 defined on the housing 104. With reference toFIG. 9D, with the pump clip 100 positioned about the fluid infusiondevice 102, the implement 282 is re-inserted into the key slot 186 androtated in a clockwise direction to move the lock button 122 from theunlock position to the lock position. In the lock position, the pumpclip 100 is securely coupled to the fluid infusion device 102.

With the pump clip 100 securely coupled to the fluid infusion device102, the pump clip 100 may be used to couple the fluid infusion device102 to an article or object associated with the user. For example, withreference to FIG. 9E, the pump clip 100 is shown with a belt 284received within the slot 260 defined between the clip 134 and theprimary surface S of the clip pivot base 128. In order to couple thebelt 284 to the pump clip 100, the user may apply a force F to the clip134 to compress the second spring 130 and move the clip 134 to thesecond, release position. In this regard, the second spring 130 appliesa second spring force FS2 that acts against the clip 134 to maintain theclip 134 in the first, clamp position. Once the second spring force FS2is less than the force F, the clip 134 moves toward the second, releaseposition. In the second, release position, the belt 284 may bepositioned between the clip 134 and the clip pivot base 128. Once thebelt 284 is positioned between the clip 134 and the clip pivot base 128,the user may remove the force F from the clip 134, which causes thesecond spring 130 to move the clip 134 from the second, release positionto the first, clamp position.

With the pump clip 100 and the fluid infusion device 102 coupled to thebelt 284, the clip base 120 is movable relative to the clip pivot base128 to compensate for torques or forces encountered by the fluidinfusion device 102. In one example, if the fluid infusion device 102encounters the torque TE, due to the fluid infusion device 102contacting a seat belt, arm of a chair, door knob, a torque applied by auser, etc., the first spring 124 resists the torque TE until the torqueTE overcomes the first spring torque FS1 of the first spring 124. Oncethe torque TE is greater than the first spring torque FS1, the clip base120 moves or pivots from the first position (FIG. 9E), toward the secondposition as shown in FIG. 10 or to a position between the first positionand the second position. With reference to FIG. 10, in the secondposition, the clip base 120 is rotated about the hinge pin 126 away fromthe clip pivot base 128, which enables the pump clip 100 to absorb thetorque TE, without breaking the pump clip 100 and/or damaging the fluidinfusion device 102. By absorbing this torque TE, the pump clip 100 alsoensures that the infusion set remains coupled to the user.Alternatively, the user may be the source of the torque TE, as themovement of the clip base 120 relative to the clip pivot base 128enables the user to rotate the fluid infusion device 102 to view ascreen of the fluid infusion device 102 without requiring a removal ofthe pump clip 100 from the belt 284. In addition, the pump clip 100 iscapable of withstanding a force of about 125 pound-force (lbf.) appliedin the first pivot axis P1 (in an instance where the pump clip 100 isunable to move to the second position) without damaging the pump clip100 and/or fluid infusion device 102. It should be noted that while thefirst spring 124 is described herein as being capable of absorbing thetorque by moving the clip base 126 away from the clip pivot base 128,the first spring 124 also absorbs forces, which are applied to the fluidinfusion device 102 at a particular position or distance from the firstspring 124. Generally, a force of less than 1.0 pound-force (lbf.)acting upward on the fluid infusion device 102 can cause the clip pivotbase 128 to rotate to deflect the force.

With reference to FIG. 11, in the second position, the clip base 120 ispivoted along the first pivot axis P1 to an angle α, which in oneexample, is about 170 degrees to about 180 degrees. In this example, theangle α is about 180 degrees. The angle α represents a maximum angulardisplacement of the clip base 120 relative to the clip pivot base 128.It should be understood that the clip base 120 may pivot to variousother positions between the angle α and the first position (FIGS. 2 and9E), depending upon an amount of the torque TE (FIG. 9E).

Thus, with reference to FIG. 11, a pivotal movement of the clip base 120about the first pivot axis P1 defined by the hinge pin 126 occurs whenthe first spring torque of the first spring 124 is overcome by thetorque TE. The first spring torque of the first spring 124 ispredetermined such that when the fluid infusion device 102 and/or pumpclip 100 experiences the torque TE via pulling, snagging, bumping, etc.,while the user is wearing the fluid infusion device 102 with the pumpclip 100, the fluid infusion device 102 and the clip base 120 rotateabout the first pivot axis P1 defined by the hinge pin 126, whichdissipates the energy from pulling, snagging, bumping, etc., so that itprevents damage to the pump clip 100 and/or the fluid infusion device102. Since the clip base 120 is mounted on the fluid infusion device 102and the second spring 130 still holds the clip 134 in the first, clampedposition onto the clip pivot base 128, the fluid infusion device 102remains attached to the user's clothing when the first spring torque ofthe first spring 124 is less than the torque TE during the pulling,snagging, bumping, etc. The first spring 124 returns the pump clip 100to the first position once the torque TE is removed.

In addition, as shown in FIG. 11, the clip 134 is movable or pivotableabout the second pivot axis P2 to an angle β based on an application ofthe force F (FIG. 9E) to the first end 266 of the clip 134, which in oneexample, may range from about 10 degrees to about 45 degrees. In thisexample, the angle β is about 16 degrees. The angle β represents anangular displacement of the clip 134 relative to the clip pivot base128. It should be understood that the clip 134 may pivot to variousother positions between the maximum of the angle β of about 45 degreesand the first position (FIGS. 2 and 9E), depending upon an amount of theforce F applied by the user (FIG. 9E).

It should be appreciated that the pump clip 100 may be constructedsomewhat differently. With reference to FIG. 12, a pump clip 100′ isshown. As this pump clip 100′ is substantially similar to the pump clip100 discussed with regard to FIGS. 1-11, the same reference numeralswill be used to denote the same or similar components. As shown in FIG.12, the pump clip 100′ is coupled to a fluid infusion device 102′. Thepump clip 100′ and the fluid infusion device 102′ cooperate to define aportable fluid infusion device system 99′. The fluid infusion device102′ may be any fluid infusion device known in the art, and thus, thefluid infusion device 102′ will not be discussed in great detail herein.Generally, the fluid infusion device 102′ is designed to be carried orworn by the user, and to be coupled to the user via the pump clip 100′.In one example, the fluid infusion device 102′ is an insulin infusiondevice, such as the MiniMed Paradigm® 700 series Insulin Pump, which iscommercially available from Medtronic MiniMed, Inc. of Northridge,Calif. The fluid infusion device 102′ may leverage a number ofconventional features, components, elements, and characteristicsdescribed in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevantcontent of which is incorporated by reference herein.

Briefly, the fluid infusion device 102′ includes a housing 104′, whichhas a length LT, which is greater than a length LT1 of the fluidinfusion device 102 (FIG. 1). Thus, the pump clip 100′ has a length LB,which is greater than a length LB1 of the pump clip 100 (FIG. 1). Thehousing 104′ has the first end 106 and the second end 108. The first end106 and the second end 108 are received within a portion of the pumpclip 100′.

The pump clip 100′ includes a clip base 120′, the lock button 122, thefirst spring 124, the hinge pin 126, the clip pivot base 128, the secondspring 130, the clamp pin 132 and the clip 134. With reference to FIG.13, the pump clip 100′ is shown detached from the fluid infusion device102′. As shown, the clip base 120′ is configured to receive the fluidinfusion device 102′. The clip base 120′ includes the first base side140 opposite a second base side 142′, the first base end 144 oppositethe second base end 146 and the aperture 148. The clip base 120′ isgenerally composed of a biocompatible polymeric material, including, butnot limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTERMX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW),Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655),Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. Inone example, the clip base 120′ is composed of Tritan® COPOLYESTERMX711. The clip base 120′ may be formed using casting, printing, moldingor another suitable technique.

The second base side 142′ is shown in greater detail. The second baseside 142 is substantially flat or planar for being positioned againstthe fluid infusion device 102′ (FIG. 12) when the fluid infusion device102′ is coupled to the pump clip 100. The second base side 142′ includesthe spring guide 156, the spring recess 158, the first relief 160, thesecond relief 162 and a projection 300. The projection 300 cooperateswith the housing 104′ to further secure the fluid infusion device 102′to the pump clip 100′. In this example, the projection 300 is receivedwithin a recess defined in the housing 104′ of the fluid infusion device102′ and cooperates with the recess to prevent the second base end 146of the clip base 120′ from sliding side to side on the fluid infusiondevice 102′.

As the pump clip 100′ is assembled the same way as the pump clip 100,the assembly of the pump clip 100′ will not be discussed in great detailherein. Moreover, as the pump clip 100′ is coupled to the fluid infusiondevice 102′ in the same manner that the fluid infusion device 102 iscoupled to the pump clip 100 as described with regard to FIGS. 9A-9E,the coupling of the fluid infusion device 102′ to the pump clip 100′will not be discussed in detail herein. With the pump clip 100′ coupledto the fluid infusion device 102′, the clip pivot base 128 is pivotablealong the first pivot axis P1 to the angle α to absorb the torque TE(the same as that shown with regard to the pump clip 100 of FIGS. 9E and11). In addition, the clip 134 is movable or pivotable about the secondpivot axis P2 to the angle β upon the application of a force to thefirst end 266 of the clip 134 (the same as that shown with regard to thepump clip 100 of FIG. 11).

It should be appreciated that the pump clip 100 may be constructedsomewhat differently, for use for a different type of fluid infusiondevice, for example. With reference to FIG. 14, a flip pump clip or pumpclip 400 is shown. As this pump clip 400 is similar to the pump clip 100discussed with regard to FIGS. 1-11, the same reference numerals will beused to denote the same or similar components. As shown in FIG. 14, thepump clip 400 is coupled to a fluid infusion device 402. The pump clip400 and the fluid infusion device 402 cooperate to define a portablefluid infusion device system 399. The fluid infusion device 402 may beany fluid infusion device known in the art, and thus, the fluid infusiondevice 402 will not be discussed in great detail herein. Generally, thefluid infusion device 402 is designed to be carried or worn by the user,and to be coupled to the user via the pump clip 400. In one example, thefluid infusion device 402 is an insulin infusion device, such as theMiniMed NGP series Insulin Pump, which is commercially available fromMedtronic MiniMed, Inc. of Northridge, Calif. The fluid infusion device402 may leverage a number of conventional features, components,elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and7,621,893, the relevant content of which is incorporated by referenceherein.

Briefly, the fluid infusion device 402 includes a housing 404. Thehousing 104 has a first end 406 and an opposite second end 408. Withreference to FIG. 15, the first end 406 defines a pump clip plate 409,which includes a first rail 410, a second rail 412 and a knob or notch414. The first rail 410 and the second rail 412 cooperate to form apocket that receives a portion of the pump clip 400 to couple the pumpclip 400 to the fluid infusion device 402. In one example, the firstrail 410 is opposite the second rail 412, and each of the first rail 410and the second rail 412 define a respective slot 410 a, 412 a. The slots410 a, 412 a slidably receive the portion of the pump clip 400 to couplethe pump clip 400 to the fluid infusion device 402. In this example, theslots 410 a, 412 a extend for a length LT4, however, the first rail 410and the second rail 412 may have any length that is suitable forreceiving the portion of the pump clip 400 to couple the pump clip 400to the housing 404. The notch 414 provides tactile and audible feedbackto the user that the pump clip 400 is coupled to the fluid infusiondevice 402. The notch 414 is substantially U-shaped, and defines a notchrecess 414 a. The notch recess 414 a includes a stop surface 414 b thatcontacts a portion of the pump clip 400 to provide tactile and audiblefeedback to the user.

With reference to FIG. 16, the pump clip 400 is shown detached from thefluid infusion device 402. The pump clip 400 includes a mount 420, ahinge pin 422, a base 424, a clamp pin 426, the second spring 130 (FIG.15) and a clip 428. With reference back to FIG. 15, the mount 420couples the pump clip 400 to the fluid infusion device 402. The mount420 is pivotable along a first pivot axis PA1 defined by the hinge pin422 between a first position (FIG. 16) and a second position (FIG. 19),and various positions in-between. The mount 420 is generally composed ofbiocompatible polymeric material, including, but not limited to,copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), PolyphenyleneSulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene(Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane(Isoplast® 2531 or Isoplast® 2510) and polycarbonate. The mount 420 maybe formed using casting, printing, molding or another suitabletechnique. The mount 420 includes a first mount side 430 opposite asecond mount side 432, a first mount end 434 opposite a second mount end436, a first lock tab 438 and a pair of opposed wings 440.

The first mount side 430 includes a first mount pin post 442 and asecond mount pin post 444 defined at the first mount end 434. The firstmount pin post 442 and the second mount pin post 444 each define arespective mount pin bore 442 a, 444 a, which are coaxially aligned toreceive the hinge pin 422. The first mount pin post 442 and the secondmount pin post 444 are rounded to provide a smooth surface in case ofcontact with the user. The first mount side 430 also defines a pair ofsloped surfaces 446 a, 446 b that extend from a respective one of thefirst mount pin post 442 and the second mount pin post 444 to a planarsurface portion 448 of the first mount side 430. The pair of slopedsurfaces 446 a, 446 b re-inforce the first mount pin post 442 and thesecond mount pin post 444.

The second mount side 432 defines a lip 450 at the second mount end 436.The lip 450 cooperates with a portion of the base 424 via a snap-fitengagement to maintain the base 424 in a first position (FIG. 16). Uponrelease of the lip 450 by a force, the mount 420 is pivotable about thefirst pivot axis PA1 defined by the hinge pin 422 to a second position(FIG. 19) and various positions in-between. In one example, a forceacting on the fluid infusion device 402 that is greater than about 3pound-force (lbf.) at the first rail 410 and the second rail 412 of thefluid infusion device 402 causes the release of the lip 450 and thepivoting of the mount 420 about the first pivot axis PA1. Thus, thesnap-fit engagement between the lip 450 and the portion of the base 424remains engaged for forces that are less than about 3 pound-force(lbf.), and the lip 450 disengages from the portion of the base 424 atforces that are greater than about 3 pound-force (lbf.). As shown, inthe first position, the mount 420 is adjacent to or next to the base424, and in the second position, the mount 420 is spaced apart from thebase 424. Generally, with reference to FIG. 17, the lip 450 is definedby a relief on the second mount side 432 that extends inwardly from thesecond mount side 432 to receive a portion of the base 424. Withreference back to FIG. 15, in one example, the lip 450 has a width W4that is configured to withstand a predetermined amount of force beforedisengaging with the base 424 to enable the mount 420 to move toward thesecond position (FIG. 19).

In this regard, with reference to FIG. 19, a pivotal movement of thebase 424 and the clip 428 against the mount 420 about the first pivotaxis PA1 defined by the hinge pin 422 occurs when the lip 450 disengagesfrom the base 424. The lip 450 disengages when the fluid infusion device402 and/or pump clip 400 experiences a force F5 via pulling, snagging,bumping, or a force applied by the user to view a screen of the fluidinfusion device 402, etc., that is greater than about 3 pound-force(lbf.) while the user is wearing the fluid infusion device 402 with thepump clip 400. Once the lip 450 disengages, the fluid infusion device402 and the mount 420 rotates about the first pivot axis PA1 defined bythe hinge pin 422 (See FIG. 20) which dissipates the energy frompulling, snagging, bumping, etc., so that it prevents damage to the pumpclip 400 and/or pump clip plate 409 of the fluid infusion device 402.Since the mount 420 is mounted on the fluid infusion device 402 and thesecond spring 130 still holds the clip 428 in the first, clampedposition onto the base 424, the fluid infusion device 402 remainsattached to the user's clothing when the lip 450 disengages under theforce during pulling, snagging, bumping, etc. With reference to FIG. 21,the pump clip 400 can return to the first position prior to theapplication of the force by applying a force F6 the fluid infusiondevice 402 on a front surface 402 a of the fluid infusion device 402 toengage the lip 450 to a second lock tab 498 of the base 424 (See FIG.21).

With reference back to FIG. 15, the second mount end 436 may also definea ramp surface 452 along a width of the second mount end 436. The rampsurface 452 facilitates the engagement of the lip 450 with the portionof the base 424. Generally, as will be discussed further herein, amovement of the first lock tab 438 toward the fluid infusion device 402(FIG. 14) engages the lip 450 with the base 424, and a movement of thefirst lock tab 438 away from the fluid infusion device 402 releases thelip 450 from the base 424. Thus, the mount 420 and the base 424 are heldtogether by the engagement of the lip 450 with the base 424.

The first lock tab 438 extends beyond the first mount end 434, andcooperates with the pump clip plate 409 to releasably couple the pumpclip 400 to the fluid infusion device 402. In addition, the first locktab 438 cooperates with the notch 414 (FIG. 14) to provide tactile andaudible feedback to the user that the pump clip 400 is coupled to thefluid infusion device 402. In one example, the first lock tab 438 isdefined on the mount 420 so as to be cantilevered with regard to themount 420. In this example, two channels 439 are defined through thefirst mount side 432 and the second mount side 434 on opposite sides ofthe first lock tab 438 to enable the first lock tab 438 to move or flexbetween a first, engaged position (FIG. 17) and a second, disengagedposition (FIG. 19) to enable the user to couple the pump clip to thefluid infusion device 402 in the first, engaged position and to uncouplethe pump clip 400 from the fluid infusion device 402 in the second,disengaged position.

With reference to FIG. 17, the first lock tab 438 includes a snap fitfeature 460, which engages with the notch 414 of the fluid infusiondevice 402 via a snap-fit engagement in the first, engaged position. Thesnap fit feature 460, in one example, is a projection, which extendsoutwardly from the first lock tab 438 on the second mount side 434. Thesnap fit feature 460 includes a stop or planar surface 462 and aninclined surface 464. The planar surface 462 extends along an axissubstantially perpendicular to a longitudinal axis L4 of the pump clip400. The planar surface 462 abuts against the stop surface 414 b of thenotch 414 (FIG. 14) when the pump clip 400 is assembled to the fluidinfusion device 402 and provides the tactile and audible feedback to theuser. The inclined surface 464 guides the first lock tab 438 into thenotch 414. The first lock tab 438 also includes a graspable portion 466.The graspable portion 466 provides a contact surface for the user toremove or uncouple the pump clip 400 from the fluid infusion device 402,as will be discussed further herein.

With reference to FIG. 15, the pair of opposed wings 440 are receivedwithin a respective one of the slots 410 a, 412 a to couple the pumpclip 400 to the fluid infusion device 402. It should be noted that thewings 440 are identical, and generally, the mount 420 is symmetric aboutthe longitudinal axis L4 (FIG. 17) of the pump clip 400. Each of thewings 440 is substantially flat or planar. Each of the wings 440 extendoutwardly from the mount 420 along opposed sidewalls 420 a of the mount420 so as to be defined on the respective sidewall 420 a between thefirst mount side 432 and the second mount side 434. In one example, eachof the wings 440 includes a tapered edge 440 a, which assists inpositioning the wings 440 within the respective one of the slots 410 a,412 a.

The hinge pin 422 movably or pivotally couples the base 424 to the mount420, and defines the first pivot axis PA1 (FIG. 16). The first pivotaxis PA1 is substantially perpendicular to the longitudinal axis L4 ofthe pump clip 400 (FIG. 16). In one example, the hinge pin 422 is astepped pin, having a diameter at a first end 422 a and a second end 422b that is less than a diameter of the hinge pin 422 at a midsection 422c. The stepped diameters along the hinge pin 422 reduces stress on themount 420 and the base 424, and provide a geometrical interference thatassists in retaining the hinge pin 422 within the first mount pin post442, the second mount pin post 444, and within a portion of the base424. The hinge pin 422 is composed of a biocompatible metal or metalalloy, such as a stainless steel. The hinge pin 422 may be formedthrough any suitable technique, such as extrusion, stamping, machining,casting, etc. The first end 422 a of the hinge pin 422 is receivedwithin a first pivot arm 472 of the base 424 and through the first mountpin post 442; and the second end 422 b of the hinge pin 422 is receivedwithin a second pivot arm 474 of the base 424 and through the secondmount pin post 444. A pivot guide 476 rotates relative to the midsection422 c of the hinge pin 422.

The base 424 is generally composed of biocompatible polymeric material,including, but not limited to, copolyester (Tritan® TX1001 or Tritan®COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon(Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P,and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) andpolycarbonate. The base 424 may be formed using casting, printing,molding or another suitable technique. The base 424 includes a firstbase end 480 opposite a second base end 482, and a first base side 484opposite a second base side 486.

With reference to FIG. 15, the first base end 480 includes the firstpivot arm 472, the second pivot arm 474 and the pivot guide 476. Thefirst pivot arm 472, the second pivot arm 474 and the pivot guide 476are spaced apart along the first base end 480 so that the first mountpin post 442 and the second mount pin post 444 may be received betweenthe first pivot arm 472, the second pivot arm 474 and the pivot guide476. In one example, the first mount pin post 442 is positioned betweenthe first pivot arm 472 and an end of the pivot guide 476; and thesecond mount pin post 444 is positioned between an opposite end of thepivot guide 476 and the second pivot arm 474. The first pivot arm 472defines a first pivot bore 472 a, which receives the first end 422 a ofthe hinge pin 422. The second pivot arm 474 defines a second pivot bore474 a, which receives the second end 422 b of the hinge pin 422. Withreference to FIG. 17, the pivot guide 476 defines a concave recess 476a, which further guides the base 424 for rotation about the hinge pin422. In this example, the concave recess 476 a contacts the midsection422 c of the hinge pin 422 for guiding the base 424 in rotation aboutthe hinge pin 422. The pivot guide 476 also defines a sloped surface 476b on the second base side 486. The sloped surface 476 b providesclearance for the movement or flexing of the first lock tab 438 duringcoupling and uncoupling of the pump clip 400 from the fluid infusiondevice 402. The first pivot arm 472, the second pivot arm 474 and thepivot guide 476 also cooperate to serve as a stop for limiting arotation of the clip 428 relative to the base 424.

With reference back to FIG. 15, the second base end 482 includes a cliprecess 488. The clip recess 488 is defined at or near the second baseend 482 and receives a portion of the clip 428. The clip recess 488cooperates with a portion of the clip 428 to define a tortuous path forclamping the pump clip 400 to an article of clothing, for example. Inthis example, the clip recess 488 is substantially rectangular; however,the clip recess 488 may have any desired shape. In this example, theclip recess 488 has an enclosed bottom surface 490, however, it shouldbe understood that the clip recess 488 may comprise an aperture, whichreceives a portion of the clip 428. With reference to FIG. 17, in oneexample, the bottom surface 490 includes an indentation 490 a, which isconfigured to mate with the portion of the clip 428 to define thetortuous path. In this example, the indentation 490 a is triangular inshape; however, the indentation 490 a may have any desired shape thatcooperates with the portion of the clip 428 to define the tortuous path.

The first base side 484 includes a pocket or recess 495, a first clippin post 494 and a second clip pin post 496. The first base side 484also defines a primary surface S1, which is substantially smooth forreceiving an article of clothing, belt, strap, etc., associated with theuser. The recess 495 is defined on the first base side 484 near thefirst base end 480 to receive the second spring 130. The spring retainer224 is defined in the recess 495, and is coupled to the second spring130 to retain the second spring 130 on the base 424. In this example, anend or the second leaf 252 of the second spring 130 engages the recess495, or pocket, within the base 424. The recess 495, or pocket togetherwith the post or the spring retainer 224, securely holds the second leaf252 of the second spring 130.

The first clip pin post 494 and the second clip pin post 496 each extendoutwardly and away from the first base side 484. The first clip pin post494 and the second clip pin post 496 are spaced apart from each otherthe first base side 484 such that the first clip pin post 494 and thesecond clip pin post 496 are on opposed sidewalls 484 a of the base 424.Generally, the first clip pin post 494 and the second clip pin post 496are spaced apart to enable the second spring 130 to be received betweenthe first clip pin post 494 and the second clip pin post 496. The firstclip pin post 494 defines a first clip bore 494 a, and the second clippin post 496 defines a second clip bore 496 a. The first clip bore 494 aand the second clip bore 496 a are coaxially aligned along axis A5 toreceive the clamp pin 426 therethrough to pivotally couple the clip 428to the base 424. Thus, the stepped hinge pin 422 is used to connect themount 420 to the base 424 which allows for pivotal movement of the mount420 relative to the base 424. The stepped hinge pin 422 is insertedthrough the pair of mount pin bores 442 a, 444 a of the first mount pinpost 442 and the second mount pin post 444 of the opposed sidewalls 420a of the mount 420 and the pair of openings (first pivot bore 472 a andsecond pivot bore 474 a) of the first pivot arm 472 and the second pivotarm 474 of the opposed sidewalls 484 a of the base 424.

With reference to FIG. 17, the second base side 486 defines the secondlock tab 498, a slot 500 and an elongated recess 502. The second locktab 498 cooperates with the lip 450. In this regard, in the lockposition, the lip 450 is received on or rests on the second lock tab498. In the unlock position, the lip 450 no longer contacts or isreleased from the engagement with the second lock tab 498 (FIG. 19).Generally, a thickness T4 of the second lock tab 498 provides aninterference onto which the lip 450 is received. In one example, thethickness T4 is between about 0.01 inches (in.) to about 0.05 inches(in.). An angle γ is the snap-fit angle between the lip 450 and thesecond lock tab 498. In one example, the angle γ is about 20 degrees toabout 85 degrees. A thickness T5 of the second lock tab 498 is about0.05 inches (in.) to about 0.125 inches (in.). Each of the thickness T4,the thickness T5 and the angle γ cooperate to determine the amount offorce the mount 420 may withstand before moving toward the secondposition (FIG. 19). In one example, the mount 420 may withstand a forceof 3 pound-force (lbf.) before the snap-fit between the lip 450 and thesecond lock tab 498 is released and the mount 420 moves toward thesecond position.

The slot 500 enables the second lock tab 498 to move or flex to releasethe lip 450. The slot 500 may be defined between the second lock tab 498and the elongated recess 502. With reference to FIG. 20, the elongatedrecess 502 may defined through a portion of the second base side 486near or adjacent to the slot 500, and may extend from near or adjacentto the slot 500 to near or adjacent to the second base end 482. Theelongated recess 502 provides a mass savings. A bore 504 is definedthrough the elongated recess 502, which assists in the formation of thebase 424 via injection molding, for example. It should be noted that thebore 504 may be optional.

The clamp pin 426 movably or pivotally couples the clip 428 to the base424, and defines a second pivot axis PA2 (FIG. 16). The second pivotaxis PA2 is substantially perpendicular to the longitudinal axis L4 ofthe pump clip 400 (FIG. 16), and is substantially parallel to the firstpivot axis PA1. Generally, the second pivot axis PA2 is offset from orspaced apart from the first pivot axis PA1 along the longitudinal axisL4 of the pump clip 400. In one example, the clamp pin 426 is a steppedpin, having a diameter at a first end 426 a and a second end 426 b thatis less than a diameter of the clamp pin 426 at a midsection 426 c. Thestepped diameters along the clamp pin 426 reduces stress on the base 424and the clip 428, and provide a geometrical interference that assists inretaining the clamp pin 426 within the first clip pin post 494, thesecond clip pin post 496, and within a portion of the clip 428. Theclamp pin 426 is composed of a biocompatible metal or metal alloy, suchas a stainless steel. The clamp pin 426 may be formed through anysuitable technique, such as extrusion, stamping, machining, casting,etc. The first end 426 a of the clamp pin 426 is received within a firstclip projection 506 (FIG. 20) of the clip 428 and through the first clippin post 494; and the second end 426 b of the clamp pin 426 is receivedwithin a second clip projection 508 of the clip 428 and through thesecond clip pin post 496. The midsection 426 c of the clamp pin 426 isreceived through the second spring 130.

The second spring 130 (FIG. 15) is coupled to the base 424. The firstleaf 250 is compressible by a force applied to the clip 428 to move theclip 428 from a first, clamped position to a second, release position.Thus, in this example, the second spring 130 is a leaf spring that isadapted to hold the clip 428 a closed position onto the base 424 andprovide desired clip force to attach to a user. The spring bore 256 ofthe second leaf 252 receives the spring retainer 224 therethrough tocouple the second spring 130 to the base 424. The body 254 couples thefirst leaf 250 to the second leaf 252, and provides a second springforce that maintains the clip 428 in the first, clamped position.

The clip 428 cooperates with the primary surface S1 of the base 424 todefine a slot, generally indicated by reference numeral 510 in FIG. 17,for receipt of an article of clothing or item associated with the user,such as a shirt, belt, strap, etc. when the clip 428 is in the first,clamped position. The clip 428 is composed of a biocompatible polymericmaterial, including, but not limited to copolyester (Tritan® TX1001 orTritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1),Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin®500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast®2510) and polycarbonate. The clip 428 may be formed using casting,printing, molding or another suitable technique. The clip 428 includes afirst side 512 opposite a second side 514, and a first end 516 oppositea second end 518.

The first side 512 is substantially smooth, and includes a recessedsurface 520 that extends from the first end 516 to the second end 518.The recessed surface 520 provides a location for a removable graphicaland/or textual indicator, such as a sticker, decal or decorative skin,which enables the user to personalize the pump clip 400. The second side514 is substantially smooth, and includes the first clip projection 506and the second clip projection 508, which extend outwardly from thesecond side 512 near the first end 516. The first clip projection 506and the second clip projection 508 are spaced apart from each other onopposed sidewalls 514 a of the clip 428 on the second side 514. In thisexample, each of the first clip projection 506 and the second clipprojection 508 includes a clip bore 522, which receives a respectivefirst end 426 a and second end 426 b of the clamp pin 426. Thus, theclip 428 is rotatably mounted to the base 424 by the stepped clamp pin426 inserted through the pair of the clip bores 522 of the first clipprojection 506 and the second clip projection 508 that extend fromopposed sidewalls 514 a of the clip 428 and the pair of the clip bores494 a, 496 a of the first clip pin post 494 and the second clip pin post496, respectively, on the opposed sidewalls 484 a of the base 424.

The second side 514 also includes a hook or clip projection 524 at thesecond end 518. With reference to FIG. 17, the clip projection 524extends outwardly from the second side 264, and is substantiallyU-shaped. The clip projection 524 cooperates with the clip recess 488 todefine a tortuous path for capturing an article of clothing or otheritem associated with the user to secure the pump clip 400 to theparticular article of clothing or other item. In one example, the clipprojection 524 includes a protrusion 524 a, which extends outwardly andaway from a surface of the clip projection 524. In this example, theprotrusion 524 a is substantially triangular, and is shaped to bereceived within the indentation 490 a of the clip recess 488. Theengagement of the protrusion 524 a and the indentation 490 a assists thepump clip 400 in further clamping or gripping onto an article ofclothing or item associated with the user, such as a shirt, belt, strap,etc. Thus, the clip projection 524 enables the clip 428 to clamp onto anarticle of clothing or other item associated with the user, and the slot510 also enables the pump clip 400 to be retained about a belt, strap,etc. associated with the user, if desired. Thus, it should be understoodthat the pump clip 400 is not limited to use just with belts or strapsassociated with a user. In addition, it should be understood that theclip projection 524 need not include the protrusion 524 a, but rather,the clip projection 524 may be rounded similar to the clip projection276 of the pump clip 100 of FIGS. 1-11, if desired.

The second side 514 also has a recess 526 which engages the first leaf250 of the second spring 130. The second spring 130 is in compression inthe assembly when the clip 428 is in the first, clamped position suchthat in the first, clamped position shown in FIG. 17, the clipprojection 524 at the second end of the clip 428 is in compressionresting in the clip recess 488 within the base 424, which providesbetter attachment of the pump clip 400 on the article associated withthe user, such as a shirt, belt, strap, etc. With reference to FIG. 18,when a force F4 is applied to the first end 516 of the clip 428 exceedsthe spring force from second spring 130, the clip 428 rotates about thesecond pivot axis PA2 defined by the clamp pin 426 and the second end518 of the clip 428 is moved to the second, release position in whichthe clip 428 is open relative to the base 424. A width W5 of the openingis at least about 0.4 inches (in.) wide for easy attachment anddetachment of the pump clip 400. The lip 450 remains engaged with thebase 424 when operating the clip 428.

In one example, with reference to FIG. 15, in order to assemble the pumpclip 400, with each of the mount 420, the hinge pin 422, the base 424,the second spring 130, the clamp pin 426 and the clip 428 formed, thebase 424 may be coupled to the mount 420 such that the lip 450 of themount 420 engages the second lock tab 498 of the base 424. With thefirst pivot bore 472 a and the second pivot bore 474 a of the base 424coaxially aligned with the mount pin bore 442 a of the first mount pinpost 442 and the mount pin bore 444 a of the second mount pin post 444,the hinge pin 422 may be inserted through the first pivot arm 472 andthrough to the second pivot arm 474 to couple the base 424 to the mount420. The second spring 130 may be positioned within the recess 495defined on the first base side 484, and the spring bore 256 of thesecond spring 130 may be coupled to the spring retainer 224 to couplethe second spring 130 to the base 424. The clip bores 522 of the firstclip projection 506 and the second clip projection 508 may be positionedover the base 424 such that the clip bores 522, the first clip bore 494a and the second clip bore 496 a are coaxially aligned. The clamp pin426 is inserted through the clip bore 522 of the first clip projection506, the first clip bore 494 a, the second clip bore 496 a and the clipbore 522 of the second clip projection 508 such that the clamp pin 426passes between the first leaf 250 and the second leaf 252 of the secondspring 130 to couple the clip 428 to the base 424.

With the pump clip 400 assembled, the pump clip 400 may be coupled tothe fluid infusion device 402. In one example, with reference to FIG.22, with the pump clip plate 409 defined on the fluid infusion device402, the wings 440 on the mount 420 are aligned with the slots 410 a,412 a of the rails 410, 412 on the housing 404. The wings 440 on themount 420 are inserted into the rails 410, 412, such that the wings 440slide in a direction D4 along the slots 410 a, 412 a until the snap fitfeature 460 engages the notch 414 on the housing 404 of the fluidinfusion device 402. Once the snap fit feature 460 engages, a tactileand audible feedback is provided to the user to indicate the pump clip400 is fully installed. With reference to FIG. 23A, the pump clip 400 isshown fully installed on the fluid infusion device 402.

With the pump clip 400 fully installed on the fluid infusion device 402,the pump clip 400 and the fluid infusion device 402 may be coupled touser. When coupled to the user, the mount 420 is movable relative to thebase 424 to compensate for forces applied to the fluid infusion device402. In one example, with reference to FIG. 20, if the fluid infusiondevice 402 encounters a force FE, due to the fluid infusion device 402encountering a seat belt, arm of a chair, door knob, a force applied bya user, etc., the lip 450 resists the force FE until the force FEovercomes the lip 450 and the lip 450 disengages with the base 424. Oncethe lip 450 disengages from the base 424, the mount 420 moves or pivotsfrom the first position (FIG. 14), toward the second position as shownin FIG. 20 or to a position between the first position and the secondposition. In the second position, the mount 420 is rotated about thehinge pin 422 away from the base 424, which enables the pump clip 400 toabsorb the force FE, without breaking the pump clip 400 and/or damagingthe fluid infusion device 402. By absorbing this force FE, the pump clip400 also ensures that the infusion set remains coupled to the user.Alternatively, the user may be the source of the force FE, as themovement of the mount 420 relative to the base 424 enables the user torotate the fluid infusion device 402 to view a screen of the fluidinfusion device 402 without requiring a removal of the pump clip 400from the user.

With reference to FIG. 20, in the second position, the mount 420 ispivoted along the first pivot axis PA1 to an angle α1, which in oneexample, is about 170 degrees to about 180 degrees. In this example, theangle α1 is about 180 degrees. The angle α1 represents a maximum angulardisplacement of the mount 420 relative to the base 424. It should beunderstood that the mount 420 may pivot to various other positionsbetween the angle α1 and the first position (FIGS. 14 and 17), dependingupon an amount of the force FE (FIG. 20).

In addition, as shown in FIG. 18, the clip 428 is movable or pivotableabout the second pivot axis PA2 to an angle β1 based on an applicationof the force F to the first end 516 of the clip 428, which in oneexample, may range from about 10 degrees to about 45 degrees. In thisexample, the angle β1 is about 17 degrees. The angle β1 represents anangular displacement of the clip 428 relative to the base 424. It shouldbe understood that the clip 428 may pivot to various other positionsbetween the maximum of the angle β1 of about 45 degrees and the firstposition (FIGS. 14 and 17), depending upon an amount of the force Fapplied by the user (FIG. 18).

In order to remove the pump clip 400 from the fluid infusion device 402,in one example, with reference to FIG. 23A, a force F7 is applied by theuser, which lifts up the first lock tab 438. In example, the force F7 isless than about 13.0 pound-force (lbf). With reference to FIGS. 23B and23C, with the first lock tab 438 lifted up, a force F8 is applied by theuser to a rear surface 438 a of the first lock tab 438 to disengage thelip 450 with the second lock tab 498 of the base 424. Once the lip 450is disengaged, the pump clip 400 may be moved in the direction of theforce F7 (FIG. 23A) to slide the wings 440 toward the notch 414. Oncethe wings 440 are removed or disengaged with the slots 410 a, 412 a ofthe rails 410, 412, the pump clip 400 is uncoupled or removed from thefluid infusion device 402.

Thus, the pump clips 100, 100′, 400 each securely couple the respectivefluid infusion device 102, 402 to the user and absorb torques or forcesacting on the respective fluid infusion device 102, 402, such as thoseencountered during an accidental displacement of the respective fluidinfusion device 102, 402 or during a user's rotation of the fluidinfusion device 102, 402 to view a screen associated with the fluidinfusion device 102, 402, etc. In this regard, the rotation of the clipbase 120 enables the respective pump clip 100, 100′ to absorb the torquewithout damaging the pump clip 100, 100′ and/or the respective fluidinfusion device 102. The rotation of the mount 420 enables the pump clip400 to absorb the force without damaging the pump clip 400 and/or therespective fluid infusion device 402. Moreover, by composing the pumpclips 100, 100′, 400 of copolyester (Tritan® TX1001 or Tritan®COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon(Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P,and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) andpolycarbonate; and metal or metal alloy, the pump clips 100, 100′, 400are resistant to exposure to chemicals, such as sun screen, body lotion,finger oils, and detergents, which prolongs a useful life of the pumpclips 100, 100′, 400. Further, the smooth first side 262 of the clip 134and the smooth first side 512 of the clip 428 provide comfort to theuser during extended periods of wear.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

What is claimed is:
 1. A pump clip for a fluid infusion device,comprising: a mount that includes wings defined on opposed sides of themount, a first lock tab to couple the pump clip to the fluid infusiondevice and a lip; a base coupled to the mount that defines a second locktab that engages with the lip to retain the mount in a first position,the mount pivotable about a first pivot axis into a second position inwhich the mount is spaced apart from the base; and a clip coupled to thebase, the clip pivotable about a second pivot axis relative to the basebetween a first, clamped position and a second, released position toreceive an article.
 2. The pump clip of claim 1, wherein the mount ispivotable from the first position to the second position based on adisengagement of the second lock tab and the lip.
 3. The pump clip ofclaim 1, wherein the base defines a recess on a first base side, and thepump clip further comprises a leaf spring retained in the recess andcoupled to the base, the leaf spring biases the clip in the first,clamped position.
 4. The pump clip of claim 1, further comprising astepped hinge pin, and the hinge pin is coupled to the mount and thebase to define the first pivot axis.
 5. The pump clip of claim 1,further comprising a stepped clamp pin, and the clamp pin is coupled tothe base and the clip to define the second pivot axis.
 6. The pump clipof claim 1, wherein the clip includes a first end opposite a second end,and the second end includes a clip projection that includes a protrusionthat mates with the base to define a tortuous path.
 7. The pump clip ofclaim 6, wherein the base has a first base end opposite a second baseend, and the second base end defines a clip recess that includes anindentation that mates with the protrusion of the clip projection todefine the tortuous path.
 8. The pump clip of claim 1, wherein the mounthas a first mount side opposite a second mount side, and the first locktab includes a snap fit feature that extends outwardly from the secondmount side to engage with the fluid infusion device.
 9. A portable fluidinfusion device system, comprising: a fluid infusion device having apump clip interface that defines a pair of rails; and a pump clipcoupled to the pump clip interface, the pump clip including: a mountthat includes wings defined on opposed sidewalls of the mount, a firstlock tab and a lip, the wings cooperate with the pair of rails toposition the pump clip on the fluid infusion device and the first locktab cooperates with the pump clip interface to releasably couple thepump clip to the fluid infusion device; a base coupled to the mount thatdefines a second lock tab that engages with the lip to retain the mountin a first position, the mount pivotable about a first pivot axis into asecond position in which the mount is spaced apart from the base; and aclip coupled to the base and the clip is pivotable about a second pivotaxis relative to the base between a first, clamped position and asecond, released position to receive an article.
 10. The portable fluidinfusion device system of claim 9, wherein based on a disengagement ofthe second lock tab and the lip, the mount pivots from the firstposition to the second position.
 11. The portable fluid infusion devicesystem of claim 9, wherein the base defines a recess on a first baseside, and the pump clip further comprises a leaf spring retained in therecess and coupled to the base, the leaf spring biases the clip in thefirst, clamped position.
 12. The portable fluid infusion device systemof claim 9, further comprising a stepped hinge pin, and the hinge pin iscoupled to the mount and the base to define the first pivot axis. 13.The portable fluid infusion device system of claim 9, further comprisinga stepped clamp pin, and the clamp pin is coupled to the base and theclip to define the second pivot axis.
 14. The portable fluid infusiondevice system of claim 9, wherein the clip includes a first end oppositea second end, and the second end includes a clip projection thatincludes a protrusion that mates with the base to define a tortuouspath.
 15. The portable fluid infusion device system of claim 9, whereinthe mount has a first mount side opposite a second mount side, the pumpclip interface defines a notch, and the first lock tab includes a snapfit feature that extends outwardly from the second mount side thatengages with the notch of the pump clip interface of the fluid infusiondevice to releasably couple the pump clip to the fluid infusion device.16. The portable fluid infusion device system of claim 9, wherein thefluid infusion device is an insulin infusion device.
 17. A portablefluid infusion device system, comprising: a fluid infusion device havinga pump clip interface that defines a pair of rails and a notch; and apump clip coupled to the pump clip interface, the pump clip including: amount that includes wings defined on opposed sidewalls of the mount, afirst lock tab and a lip, the wings configured to be slidably receivedwithin the pair of rails to position the pump clip on the fluid infusiondevice and the first lock tab cooperates with the notch of the pump clipinterface to releasably couple the pump clip to the fluid infusiondevice; a base coupled to the mount that defines a second lock tab thatengages with the lip to retain the mount in a first position, the mountpivotable about a first pivot axis into a second position in which themount is spaced apart from the base; and a clip coupled to the base andthe clip is pivotable about a second pivot axis relative to the basebetween a first, clamped position and a second, released position toreceive an article.
 18. The portable fluid infusion device system ofclaim 17, wherein based on a disengagement of the second lock tab andthe lip, the mount pivots from the first position to the secondposition.
 19. The portable fluid infusion device system of claim 17,further comprising a stepped hinge pin, and the hinge pin is coupled tothe mount and the base to define the first pivot axis.
 20. The portablefluid infusion device system of claim 17, further comprising a steppedclamp pin, and the clamp pin is coupled to the base and the clip todefine the second pivot axis.